UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062486 |
|---|---|
| Receipt number | R000071519 |
| Scientific Title | Association Between Oral Hygiene Status at Admission to a Convalescent Rehabilitation Ward and Discharge Motor FIM Effectiveness in Older Patients With Proximal Femoral Fracture |
| Date of disclosure of the study information | 2026/08/05 |
| Last modified on | 2026/08/05 21:45:22 |
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Basic information
Public title
Association Between Oral Hygiene Status at Admission to a Convalescent Rehabilitation Ward and Discharge Motor FIM Effectiveness in Older Patients With Proximal Femoral Fracture
Acronym
Association Between Oral Hygiene Status at Admission to a Convalescent Rehabilitation Ward and Discharge Motor FIM Effectiveness in Older Patients With Proximal Femoral Fracture
Scientific Title
Association Between Oral Hygiene Status at Admission to a Convalescent Rehabilitation Ward and Discharge Motor FIM Effectiveness in Older Patients With Proximal Femoral Fracture
Scientific Title:Acronym
Association Between Oral Hygiene Status at Admission to a Convalescent Rehabilitation Ward and Discharge Motor FIM Effectiveness in Older Patients With Proximal Femoral Fracture
Region
| Japan |
Condition
Condition
Hip fracture/Proximal femoral fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine whether oral hygiene status at admission is associated with motor FIM effectiveness at discharge in older patients with proximal femoral fractures.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to determine whether oral hygiene status at admission is associated with motor FIM effectiveness at discharge in older patients with proximal femoral fractures.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Motor FIM Effectiveness at Discharge
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Study period: Patients aged 65 years or older with proximal femoral fractures who were admitted to the convalescent rehabilitation ward at our hospital between June 1, 2024, and January 31, 2026, and who had been discharged by the time of final study population determination.
Key exclusion criteria
Patients who died or were transferred to another hospital because of an acute deterioration before discharge.
Patients with a length of stay in the convalescent rehabilitation ward of less than 7 days.
Patients who developed postoperative orthopedic complications that prevented continuation of rehabilitation (including implant cut-out, refracture, or cases requiring reoperation).
Readmission cases of the same patient (only the first admission was included).
Patients who underwent conservative treatment during the acute-care hospitalization.
Patients who declined to participate in the study, or whose legally authorized representative declined participation.
Patients with pathological fractures due to malignant tumors.
Patients with a motor FIM score of 91 (full score) at admission.
Patients with missing data.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Tenjin |
Organization
CloverHospital
Division name
Department of Gastroenterology and General Internal Medicine
Zip code
251-0025
Address
3-3-6 Kugenuma-Ishigami, Fujisawa, Kanagawa 251-0025, Japan
TEL
08099833332
7716ttay09170427@gmail.com
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Tenjin |
Organization
CloverHospital
Division name
Department of Gastroenterology and General Internal Medicine
Zip code
2510033
Address
3-3-6 Kugenuma-Ishigami, Fujisawa, Kanagawa 251-0025, Japan
TEL
08099833332
Homepage URL
7716ttay09170427@gmail.com
Sponsor or person
Institute
Clover Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japanese society of rehabilitaion
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Medical Association Institutional Review Board (IRB)
Address
Kanagawa Medical Association General Medical Center, 3rd Floor, 3-1 Fujimi-cho, Naka-ku, Yokohama, Kanagawa 231-0037, Japan
Tel
0452417000
n-oda@kanagawa.med.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2604
Org. issuing International ID_1
Kanagawa Medical Association General Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design
A single-center retrospective observational study.
Study population
Patients aged 65 years or older with proximal femoral fractures who were admitted to the convalescent rehabilitation ward of our hospital between June 1, 2024, and January 31, 2026.
Variables collected
Age, sex, motor FIM score at admission, cognitive FIM score at admission, OHAT-J score at admission, Charlson Comorbidity Index, and CRP level at admission.
Primary outcome
Motor FIM effectiveness at discharge.
Management information
Registered date
| 2026 | Year | 08 | Month | 05 | Day |
Last modified on
| 2026 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071519
